Ignite Creation Date:
2024-05-06 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03647904
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2018-01-25
Brief Title:
The SEMS Project Staying Employed With MS
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
The SEMS Project Staying Employed With MS
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Description of Project Multiple sclerosis MS a disorder of young and middle aged adults is known to have a grave impact on ones well-being and incurs a significant cost to society due to the nearly 80 rate of unemployment Over the past few decades research has focused on increasing our understanding of the factors that lead to these high rates of unemployment in MS and ways to mitigate such factors However the majority of investigations examining the causes of unemployment in MS have been retrospective and limited their focus to factors such as demographics disease severity and symptoms of MS eg fatigue and or work place features and accommodations Few have examined the more intrinsic or person-specific factors eg personality coping health-related behaviors which are also likely to significantly contribute to rates of unemployment in MS In fact these investigators have shown that personality characteristics anxiety depression coping and self-efficacy differ between individuals who are considering leaving the workforce and those staying employed even in the presence of comparable demographics and disease variables Based on these findings and the knowledge that fatigue and cognition also greatly contribute to this decision these investigators have proposed a comprehensive intervention that will target both the disease and person-specific factors in hope of assisting individuals with MS maintain their employment the ultimate goal being to improve the overall quality of life and health of individuals with MS The proposed modular intervention will be tailored to the individual based on a preliminary assessment and consist of cognitive rehabilitation fatigue and symptom management wellness intervention psychological intervention and occupational rehabilitation Outcomes will be assessed following such intervention with the goal being either job maintenance or comparable life activities that will ensure continuity of purpose and satisfaction in life health and health maintenance and overall well-being
Detailed Description:
Multiple sclerosis MS a disorder of young and middle aged adults has a grave impact on ones well-being and incurs a significant cost to society due to the nearly 80 rate of unemployment12 Over the past few decades research has focused on increasing our understanding of the factors that lead to the high unemployment rates in MS and ways to mitigate such factors However the majority of investigations examining the determinants of unemployment in MS have been retrospective and limited in their focus to factors such as demographics disease symptoms and severity andor work place features and accommodations Few have examined the more intrinsic or person-specific factors eg personality coping health-related behaviors which are also likely to contribute to unemployment rates in MS In fact one of the earliest investigations examining the common factors associated with unemployment in MS asserted that premorbid personality education level quality of environment and socialfamily network were likely to affect how an individual with MS reacted to their illness including attitudes towards employment2 By applying a new conceptual model that incorporates such person-specific factors and controls for the more typical demographic and disease variable predictors of unemployment in persons with MS these investigators have shown that personality characteristics anxiety depression coping and self-efficacy differ between individuals who are considering leaving the workforce and those who stay employed Perhaps most striking was the finding that these individuals had an average disease duration of only 67 years compared to 104 years of those staying employed Moreover 62 were within 5 years of diagnosis compared to only 36 among those staying employed This nearly double rate may reflect poor adjustment to illness rather than a result of greater disability per se Based on these findings these investigators postulate that individuals who are considering leaving the workforce or reducing work hours could benefit from early intervention targeting person-specific vulnerability factors Such intervention should not only address the cognitive psychological and physical consequences of MS but also attend to vital premorbid and psychological factors eg anxiety coping self-efficacy which in some ways may better account for why individuals leave the workforce Moreover given the negative psychological and health consequences of unemployment in general it is imperative that we assist such individuals in maintaining their employment and adjustment to MS to ward of further reductions in overall well-being and quality of life Thus the proposed investigation aims to assist individuals with MS maintain their employment by developing a comprehensive intervention that will target both the disease and person-specific factors associated with unemployment in MS the ultimate goal being to improve the overall quality of life and health of individuals with MS The proposed modular intervention will be tailored to the individual based on a preliminary assessment and it may consist of any or all relevant components of cognitive rehabilitation fatigue and symptom management wellness intervention and psychological intervention Outcomes will be assessed following such intervention with the goal of enhancing greater commitment to work and job maintenance that will ensure continuity of purpose and satisfaction in life health and health maintenance and overall well-being We will also assess change and process variables throughout the intervention to gain a better sense of the factors that facilitate change across these interventions In sum the specific aims of the proposed investigation are to
Specific Aim 1 Develop and pilot a comprehensive and personally responsive modular intervention to assist individuals with MS remain in the workplace and examine the factors most associated with such change
Specific Aim 2 Examine the immediate and long-term 3 month outcomes of this intervention on functioning well-being self-efficacy disease management health and overall quality of life
Specific Aim 1 Develop and pilot a comprehensive and personally responsive modular intervention to assist individuals with MS remain in the workplace and examine the factors most associated with such change
Specific Aim 2 Examine the immediate and long-term 3 month outcomes of this intervention on functioning well-being self-efficacy disease management health and overall quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None